Senior Scientist I Reviewer

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds top authorities in health and science to develop quality standards for medicines dietary supplements and food ingredients. USPs fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1300 hardworking professionals across twenty global locations to deliver the mission to strengthen the supply of safe quality medicines and supplements worldwide.

At USP we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create the partnerships we build and the conversations we foster we affirm the value of Diversity Equity Inclusion and Belonging in building a world where everyone can be confident of quality in health and healthcare.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of but not limited to race ethnicity physical and mental abilities education religion gender identity and expression life experience sexual orientation country of origin regional differences work experience and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Brief Job Overview

This is a handson nonsupervisory position in USPs Reference Standards Laboratory (RSL). In this role the Senior Scientist I conducts routine and nonroutine analyses of raw materials validation and stability samples by appropriate analytical methods. The Senior Scientist I works on complex technical problems in analytical chemistry that directly support revisions to the USPNF including the evaluation of candidate reference standards the evaluation development or validation of official methods the evaluation of packaging materials stability studies troubleshooting of equipment and other general research in analytical chemistry. The Senior Scientist I serves as a technical resource for a variety of analytical techniques for RSL staff and staff from other departments. The Senior Scientist I may execute 1025 of their work at the bench level.

In addition this position will include project management technical leadership and training of RSL employees. The incumbent in this role will utilize their technical expertise knowledge of current regulatory guidelines strong organizational and communication skills to ensure safe highquality efficient technical oversight and resolution of technical problems. They will generate data and issue high quality reports serve as a point of contact with stakeholders outside to RSL to resolve any encountered issues and perform review of colleagues data and reports.

How will YOU create impact here at USP

In this role at USP you contribute to USPs public health mission of increasing equitable access to highquality safe medicine and improving global health through public standards and related programs. In addition as part of our commitment to our employees Global People and Culture in partnership with the Equity Office regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

The Senior Scientist I RSL has the following responsibilities:

• Serves in the role of Project Leader / Reviewer and reviews analytical data and/or generates laboratory reports.
• Provides project and technical support within RSL including managing project tasks via interacting with clients on activities related to the evaluation of candidate reference materials and collaborating with RSL leaders other departments and/or customers to create an achievable work schedule.
• Performs research in reference standards analysis including method development and validation.
• Organizes implements and evaluates collaborative studies.
• Conducts scientific seminars and presents publications.
• Reviews interprets and evaluates scientific literature.
• Serves as a mentor for scientists in the laboratory regarding technical knowledge work ethic and professional conduct.
• Represents RSL in internal customer meetings to receive/deliver information requests and requirements.
• Takes the lead in working with other departments to solve both technical and processrelated issues.
• Investigates evaluates and recommends the purchase of laboratory equipment.
• Prepares study reports and presents data internally within USP and externally to customers; serves as the technical lead for deviation investigation outofspecification or aberrant results and process changes; troubleshoots assay and instrumentation issues. This involves data mining trending and analysis to identify problems or determine process control.
• Leads peer review of laboratory reports.

Who is USP Looking For

The successful candidate will have a demonstrated understanding of our mission commitment to excellence through inclusive and equitable behaviors and practices ability to quickly build credibility with stakeholders along with the following competencies and experience:

• Ph.D. in Science and 5 years of relevant laboratory experience or
• M.S. in Science and 7 years of relevant laboratory experience or
• B.A. /B.S. in Science and 10 years of relevant laboratory experience.

Additional Desired Preferences

• Experience interpreting and reporting NMR data.
• Ability to lead projects to completion with a high degree of scientific expertise. Excellent communication and presentation skills both verbal and written
• Proficient with testing involving compendial methods for raw materials (USP BP EP etc..
• Expert in HPLC and GC method development and troubleshooting proficient in other related analytical instrumentation (ICP KF UV) handson knowledge of LC/MS or GC/MS preferred.
• Prior experience in a highvolume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.
• Record of leading projects to ensure work is delivered on time and is the highest possible quality.
• Skill to lead projects and build technical expertise in RSL staff by serving as a role model and mentor.
• Ability to conduct research projects independently and to anticipate troubleshoot and solve complex technical problems.
• Experience and proven track record of introducing new or innovative technologies to the laboratory

Supervisory Responsibilities

None this is an individual contributor role.

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From companypaid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial wellbeing is protected.

Compensation

Base Salary Range: USD $110500.00 $144000.00 annually.
Target Annual Bonus: Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidates skill set experience qualifications equity and other jobrelated reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Required Experience:

Senior IC